NCT05456321

CIFASD 5 tDCS and Cognitive Training

tDCS and Cognitive Training as a Neurodevelopmental Intervention in FASD

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized placebo-controlled trial of cognitive training with transcranial direct current stimulation (tDCS) for children and adolescents (ages 8 - 17 years) with prenatal alcohol exposure (PAE).

Detailed description

Prenatal alcohol exposure (PAE) has profound detrimental effects on brain development and, as a result, has permanent consequences for cognition, learning, and behavior. Individuals with Fetal Alcohol Spectrum Disorders (FASD) commonly have a range of neurocognitive impairments that directly lead to practical problems with learning, attention, working memory, task planning/execution, and decision making, among other areas of functioning. Despite the profound public health burden posed by FASD, there have been very few treatment studies in this population. This study will examine the effects of a cognitive remediation training augmented with transcranial direct current stimulation (tDCS) in children and adolescents with PAE. The study involves a baseline visit with cognitive testing, 5 sessions of tDCS (including the baseline visit) with active and sham arms, a 6th visit for cognitive testing.

Conditions

• Fetal Alcohol Spectrum Disorders

Interventions

Type	Name	Description
DEVICE	Active tDCS	Active Transcranial Direct Current Stimulation (tDCS)
BEHAVIORAL	Cognitive Training	Computerized Cognitive Training
DEVICE	Sham tDCS	Sham Transcranial Direct Current Stimulation (tDCS)

Timeline

• Start date: 2022-11-10
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2022-07-13
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study